BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DW ARTHROSCOPY FLUID MANAGEMENT DEV

    MDR report key: 18122148 · Received November 13, 2023

    Report

    Report Number
    1220246-2023-08699
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    December 2, 2021
    Report Date
    November 13, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039377
    PMA / PMN Number
    K083707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION WAS CONFIRMED. VISUAL INSPECTION DID NOT SHOWED ANY PHYSICAL DAMAGED TO THE RETURNED DEVICE. FURTHER REVIEW OF THE PUMP SUB-ASSEMBLY AND COMPONENTS, SHOWED NO ISSUES WITH THE LATCH DOOR OR TUBING CONNECTOR. THE RETURNED AR-6480 DUALWAVE PUMP WAS ASSEMBLED WITH A NEW AR-6410 AND AR-6430 TUBING'S AND WERE TESTED AND EVALUATED UNDER NORMAL USE CONDITIONS TO SEE IF THE ISSUE(S) REPORTED COULD BE REPRODUCED. THE PUMP WAS POWERED ON AND IT WAS NOTICED THAT THE MOTOR ON THE INFLOW SIDE WAS LOUD AND THE MOTOR ON THE OUTFLOW HAD WORN OUT. COMPLAINT TUBE SETS WERE NOT SENT FOR EVALUATION. BASED ON THE AGE OF THE DEVICE THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT SIDE (OUTFLOW) OF THE DEVICE IS NOT WORKING PROPERLY AND DOES NOT ROTATE/SPORADICALLY DURING THE OPERATION OF THE DEVICE. A REPLACEMENT OF THE TUBING AND CHECKING FOR PROPER FIT RESULTED IN NO IMPROVEMENT. AFTER EXCHANGING THE DEVICE WITH AN IDENTICAL DEVICE NO MORE PROBLEMS OCCURRED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 06-DEZ-2021. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING THE SURGERY ON THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. ORIGINAL ARTHREX TUBING WAS USED WITH THE PUMP. PART- AND BATCH NUMBER OF THE TUBING IS NOT AVAILABLE, AS THE TUBING WAS ALREADY DISCARDED. NO ERROR MESSAGES WERE DISPLAYED WHEN THE ERROR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239979 DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV 10022003 00888867039377

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown